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close this bookUNAIDS-Sponsored Regional Workshops to Discuss Ethical Issues in Preventive HIV Vaccine Trials (UNAIDS, 2000, 52 p.)
close this folderWORKSHOP REPORTS
close this folderBANGKOK, THAILAND, 20-22 APRIL, 1998
View the document1. Collaboration in Phase I, II and III Trials
View the document2. Community
View the document3. Ethical and Scientific Review
View the document4. Intellectual Property
View the document5. Control Arm in Trials
View the document6. Informed Consent
View the document7. Gender, Pregnancy and Breast-Feeding
View the document8. Children
View the document9. Protection from Discrimination
View the document10. Vaccine-Induced HIV-Seropositivity
View the document11. Counselling
View the document12. Post-Exposure Prophylaxis (PEP)
View the document13. Treatment and Care
View the document14. Compensation
View the document15. Availability of Vaccine

6. Informed Consent

Consensus:

Informed consent should ultimately be provided by the individual participant. The issue of informed consent was felt to have been inadequately covered by the study questions and during discussions, given its importance in the ethical conduct of trials.

Discussion:

In the context of discordant couples (the case presented in the scenarios), the group agreed that family and community would need to be involved in the individual’s final decision to participate, and many thought that the sexual partner of the vaccinee should also provide informed consent.

Regarding those who suffer from mental disorders, the group agreed that they should not be enrolled in a trial under any circumstances. This does not preclude these individuals receiving a vaccine that has been proven effective following completion of an efficacy trial.

Groups that may have difficulty in giving individual informed consent include bonded sex workers, prisoners, and military recruits.

Controversy:

Differences between the informed consent process in Asia and the West were discussed. There was a strong sentiment among representatives of Asian countries that the degree to which communities must be involved in the decision-making process of the participant and the influence of community leaders on the individual’s decision are greater in the East than in the West. There was also concern that study participants in Asia (particularly in rural communities) are more likely to make decisions based on the opinion of the community or its leader than on a thorough understanding of the study protocol. Representatives of Western countries argued that this also occurs in the West, and that the difference between the two cultures is unlikely to be significant. This issue surfaced several times during the workshop.